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Guide: Phase III Pagoda trial is also evaluating PDS for the treatment of diabetic macular edema, and patients are being recruited.
compilation, Roche announced the detailed results of phase III OFAWAY trial.
this random, multicenter, open-label study was conducted in 418 patients with neonatal vascular (wet) age-related macular degeneration (nAMD), who received at least three anti-VEGF injections in the six months prior to the study screening and were shown to be responsive to VEGF therapy.
study compared the new in-eye administration system ranibizumabPDS (Rebead Monoanti-Glass Implant) at a fixed interval of 6 months with a monthly injection of raybead monovirus in the glass.
nAMD is the primary cause of blindness in people 60 years of age and older, and rejuvevitagain is currently the standard treatment for nAMD, but patients need to go to the hospital regularly (once a month) for intra-eye injections.
PDS is a permanent, refilled drug, about the size of a grain of rice, designed to continuously release custom-formulated rebeads in the eye over time, reducing the number of injections in nAMD patients per year.
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's injection supplement to PDS data shows that the Archway study reached the primary endpoint: 98.4 percent of PDS patients were able to rehydrate every six months without additional treatment, and the visual results were consistent with those receiving a monthly retardation.
specific data for: in the PDS group, patients' vision increased by an average of 0.2 letters from baseline testing, 98.4% of patients maintained a fixed 6-month refill plan during the first refill cycle, and patients receiving rebead suptinoten injection sedituated each month had an average of 0.5 letters of increase in vision from baseline testing.
, according to pre-defined research standards, PDS showed non-inefficiancy, equivalent to a monthly rebead monoto-injection.
, PDS has the same effect as the once-a-month raybead monotorinis in controlling retinal thickness, with the average change in the center thickness of patients in the two groups to less than 10 m.
studies, patients were well tolerated with PDS implants and refills, PDS had a good risk profile of benefits, and safety was comparable to a monthly rebead monoto-injection.
note, PDS was the first nAMD therapy to achieve phase III positive results over an extended treatment interval.
According to Archway, PDS has the potential to reduce the number of treatments in nAMD patients from 12 times per year to 2 per year without affecting efficacy, which will significantly reduce the patient's treatment burden.
the results of the Archway study will be submitted to regulators around the world to support regulatory approval for PDS treatment nAMD.
In addition to Archway, Portal's Long Extended Research is investigating the long-term safety and tolerance of PDS treatments for nAMD.
, the Phase III Pagoda trial is also evaluating PDS for the treatment of diabetic macular edema and is currently recruiting patients.
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